510(k) · Cleared
Recalled · Class I · 2026Arrow Large-Bore Dual Lumen Hemodialysis Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · LFJ Catheter, Subclavian
Cleared on Jan 3, 1990 after a 124-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 24 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jan 3, 1990
- Review
- 124 days
- Class
- Class II
- Product code
- LFJ
- Recalls
- 1 (1 Class I)
- Predicates
- 0
23 later devices descend from it, 2 citing it directly. 5 of the 24 devices in this family, counting this one, have a Class I recall.
- This deviceK895417 Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990
- Descendant · cites it directly · 13 of its ownK970864 Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK014241 Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A…Alsius Corp. · 2003 · Recalled
- Descendant · cites it directly · 8 of its ownK993933 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip…Arrow Intl., Inc. · 2000 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK101987 Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and…Zoll Circulation · 2010
- Descendant · 3 generations on · 4 of its ownK150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter…Zoll Circulation, Inc. · 2015 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970864 Arrow-Howes Large Bore Multi-Lumen Central…cites it directly · 1997
- K993933 14 FR Two-Lumen Hemodialysis Catherization Kit…cites it directly · 2000
- K143102 Multi-Lumen Acute Hemodialysis Catheter for High…2 generations on · 2015
- K011761 Mac Two-Lumen Central Venous Kit with Arrowg Ard…2 generations on · 2001
Most influential descendants
Showing 5 of 23 · See all- K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · cites it directly13descendants
- K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp. · 2003 · 2 generations on11descendants
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…Arrow Intl., Inc. · 2000 · cites it directly8descendants
- K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation · 2010 · 3 generations on6descendants
- K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895417 | Arrow Large-Bore Dual Lumen Hemodialysis Kit | Arrow Intl., Inc. | 1990 | — |
| +1 | K970864 | Arrow-Howes Large Bore Multi-Lumen Central Venous Catheters | Arrow Intl., Inc. | 1997 | Class I |
| +2 | K014241 | Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500D | Alsius Corp. | 2003 | 6 |
| +1 | K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard… | Arrow Intl., Inc. | 2000 | Class I |
| +3 | K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro… | Zoll Circulation | 2010 | — |
| +3 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY… | Zoll Circulation, Inc. | 2015 | 21 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
| 2000 | 1 | 1 |
| 2001 | 1 | 1 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2381-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 11 Class I recall
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · Cites it directly · ◆ in the 2000 descendants bar of FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis…Arrow Intl., Inc. · 2001 · 2 generations on · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K970864 (Arrow Intl., Inc., 1997) has gone furthest, with 13 descendants of its own.
How does its category compare?
All LFJ devicesLFJ Catheter, Subclavian: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFJ
FDA has decided no LFJ device since 2007.
Median 510(k) review, days · LFJ
Too few LFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LFJ
1so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LFJ
28in 2025
MAUDE reports naming product code LFJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 0 | — | 0 | 45 |
| 2011 | 0 | — | 0 | 23 |
| 2012 | 0 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 0 | — | 0 | 31 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 45 |
| 2020 | 0 | — | 0 | 43 |
| 2021 | 0 | — | 0 | 37 |
| 2022 | 0 | — | 0 | 34 |
| 2023 | 0 | — | 0 | 44 |
| 2024 | 0 | — | 0 | 48 |
| 2025 | 0 | — | 0 | 28 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K895417 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895417: Arrow Large-Bore Dual Lumen Hemodialysis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895417
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026